An appeal by Johnson & Johnson to overturn a $124 million verdict against the company has been rejected by the U.S. Supreme Court. The verdict involved the pharmaceutical giant’s drug Risperdal, an atypical antipsychotic the state of South Carolina alleged was illegally marketed by the company.

Lawsuit alleges deceptive marketing

South Carolina originally filed their lawsuit in April 2007, alleging Johnson & Johnson and their subsidiary Janssen violated marketing laws when they sent letters to physicians in the state making improper claims and downplaying some of the risks associated with Risperdal. The initial verdict, which was handed down in 2011, ordered the companies to pay $327 million.

Johnson & Johnson has successfully had the amount of the verdict lowered twice through appeals and was trying to reduce the amount a third time when it appealed to the Supreme Court. The company has argued that the amount of the verdict was excessive. Johnson & Johnson has also successfully appealed a larger verdict in Arkansas, where $1.2 billion in awards involving deceptive marketing practices was reduced to $7.5 million on a settlement between the state and the pharmaceutical company.

However, the U.S. Supreme Court refused to hear the appeal, which lets the June ruling by the South Carolina Supreme Court stand. That court cut a number of the original violations filed against the company, but refused to throw out a lower court’s ruling that Johnson & Johnson and Janssen violated South Carolina’s Unfair Trade Practices Act with their deceptive marketing of their drug. That court lowered the Risperdal verdict amount from $327 million to $136 million, which was further reduced to $124 million by the same court in June of last year.

Risperdal and gynecomastia risks

Risperdal was originally approved by the FDA in 1994 to treat schizophrenia and symptoms of bipolar disorder in adults. Since that time, approval has been extended to use in children and teens to treat the same conditions. However, the drug has also been prescribed off-label to address symptoms of autism and ADHD.

Since that time, Risperdal use in younger male patients has been associated with a condition known as gynecomastia or male breast growth. In some cases, the breast size became quite significant, causing pain and embarrassment to the boys that developed the condition. Often, the only way to address gynecomastia is through breast reduction surgery.

Risperdal has also been prescribed off-label to older adults, at the urging of Johnson & Johnson, to treat some of the symptoms of dementia. However, an increased risk of death for these elderly patients prompted the FDA to require a black box warning on Risperdal packaging to alert patients and physicians to this risk.

Now, hundreds of individuals have filed Risperdal lawsuits against Johnson & Johnson and Janssen, claiming the manufacturer failed to provide sufficient warning about the risks associated with the drug.

States like South Carolina have also filed lawsuits, alleging the company violated fair business practices with deceptive marketing campaigns. Now, it appears Johnson & Johnson will be required to pay the $124 million verdict in South Carolina, because the defendant has exhausted all of its appeals in the legal process.

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